Multicenter Clinical Study to Examine the Efficacy and Safety of Zarzenda in Patients With Hand Eczema

Hand Eczema Clinical Trial

Official title:

A Multicenter, Open Uncontrolled Clinical Study to Examine the Efficacy and Safety of Zarzenda in the Management of Hand Eczema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488241
• Other study ID #: 1401663
• Status: Completed
• Phase: Phase 4
• Start date: June 2007
• Est. completion date: September 2007

Study information

• Verified date: October 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To show efficacy of Zarzenda in the treatment of hand eczema

Description:

The objective of the study is to demonstrate efficacy and safety of Zarzenda (a medical device) in the management of hand eczema.

Other known NCT identifiers

• NCT01646658

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mild to moderate hand eczema for at least 3 months
• At least 4 weeks have passed since use of systemic treatment for eczema
• At least 4 weeks have passed since any vaccination
• At least 1 week has passed since last topic treatment on hands with corticosteroids
• Agree to use adequate contraceptive method if of childbearing potential
• Willingness to avoid excessive exposure to sunlight and avoid skin irritants

Exclusion Criteria:

• Pregnancy, breast feeding
• Severe excoriations on the hands
• Need for systemic treatment for atopic dermatitis
• Known sensitivity to Zarzenda and/or to extract of nut butyrospermum parkii (shea)
• Known immune deficiency
• Concomitant infection on hands

Related Conditions & MeSH terms

• Eczema
• Hand Eczema

Intervention

Device:
• Zarzenda
Topically applied daily for 2 weeks

Locations

Country	Name	City	State
Germany	Intendis GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand eczema severity index (HECSI)at the end of study		End of study compared to baseline
Secondary	Investigator's Global Assessment		End of study compared to baseline
Secondary	Patients assessment of itch		End of study compared to baseline
Secondary	Hand surface area		End of study compared to baseline
Secondary	Clinical signs of hand eczema		End of study compared to baseline